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Urinary stress incontinence, defined as the involuntary loss of urine from the urethra due to an increase in intra-abdominal pressure, is a common condition, affecting 6.5 million women in the United States. Conservative therapy usually includes pelvic floor muscle exercises, biofeedback (see Biofeedback policy), pelvic electrical stimulation (see Pelvic Floor Stimulation as a Treatment of Urinary Incontinence policy), or periurethral bulking agents such as collagen (See Periurethral Bulking Agents for the Treatment of Incontinence policy) might also be tried.. Various surgical options are considered when conservative therapy fails, including most prominently various different types of bladder suspension procedures, which intends to reduce bladder neck and urethra hypermobility by tautening the endopelvic fascia.  For example, for colposuspension (i.e., the Burch procedure), sutures are placed in the endopelvic fascia and fixed to Cooper's ligament or retropubic periosteum, which in turn creates a floor or hammock underneath the bladder neck and urethra.  Recently, radiofrequency energy has been investigated as a technique to shrink and stabilize the endopelvic fascia, thus improving the support for the urethra and bladder neck.  Two radiofrequency devices have been specifically designed for the treatment of urinary stress incontinence, which may be performed as outpatient procedures under general anesthesia.  The SURx Transvaginal System is a radiofrequency device that has been specifically designed as a transvaginal treatment of urinary stress incontinence that can be performed as an outpatient procedure under general anesthesia:

• SURx Transvaginal System: This involves making an incision through the vagina lateral to the urethra, exposing the endopelvic fascia. Radiofrequency energy is then applied over the endopelvic fascia in a slow sweeping manner, resulting in blanching and shrinkage of the tissue.
• Renessa® procedure: The procedure involves passing a specially designed four-needle radiofrequency probe through the urethral opening into the urethra and then into the bladder. Once the probe is in position, a small balloon is inflated to keep it in position during the procedure. Radiofrequency energy is then delivered for 60 seconds to the four needles which are deployed from the probe into the tissue of the bladder neck and upper urethra. Tissue temperatures of 65 to 75 degrees C are generated; at this temperature, focal microscopic denaturation of collagen occurs. The procedure is repeated nine times so that collagen is denatured at 36 tissue sites.

The SURx Transvaginal System received clearance to market through the U.S. Food and Drug Administration (FDA) 510(k) process in 2002.  According to the FDA, the device “is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.” As of 2006, the SURx is no longer marketed in the U.S.  

Novasys Medical received clearance to market the Renessa® transurethral RF system through the U.S. Food and Drug Administration (FDA) 510(k) process in 2005. The device is indicated for the transurethral treatment of stress urinary incontinence due to hypermobility.

Transurethral radiofrequency tissue remodeling as a treatment of urinary stress incontinence is considered investigational.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)

2/18/2008: Policy reviewed, no changes

12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions

04/26/2010: Policy description updated regarding status of devices and treatment approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.

03/09/2011:  Added new CPT code 53860 to the Code Reference section.

04/19/2012:  Policy reviewed; no changes to policy statement. Removed deleted CPT code 0193T from the Code Reference section.

Non-Covered Codes